TMA said in a letter to CMS Acting Administrator Marilyn Tavenner that the proposed revision's requirement that hospitals have an organized medical staff that operates under bylaws approved by the governing board is "silent as to the important role the medical staff has in the creation and adoption of medical staff bylaws. TMA is concerned that CMS' omission of this important piece of a well-functioning relationship between a hospital's governing body and the organized medical staff sends a message that CMS does not recognize the importance of the self-governing medical staff."

By omitting such language, TMA said, "CMS could be setting a standard that hospital administrators and their attorneys may create organized medical staff bylaws without medical staff involvement in the process. Hospital administration does not have the medical knowledge to create sound medical staff bylaws…" The association added that it "likely would violate the independent medical judgment, separated from lay influence, needed to achieve high quality medical care. A prudent hospital administration should welcome the organized medical staff’s development of its bylaws to ensure a safe and effective hospital."

The letter from TMA General Counsel Donald P. "Rocky" Wilcox, JD, and Assistant General Counsel Andrea Schwab, JD, CPA, urged CMS "to clearly state in the rule that the hospital must have an organized medical staff that operates under bylaws 'created, adopted, and submitted by the medical staff and approved by the governing body.' The medical staff’s development and adoption of medical staff bylaws is critical to quality care and safety in the hospital, and this must be made clear in the rule."

In a separate letter, TMA, the American Medical Association, state medical societies, and national specialty societies told CMS the proposal"would cause serious harm to patients" by diluting physicians' ability to set professional and clinical standards for patient care. The groups said they support the effort to reduce regulatory burdens. However, they wrote, the revisions to the medical staff and governing body conditions of participation "do not, in our view, have a substantiated patient health or safety rationale…"

CMS says its proposal would "reduce the regulatory burden on hospitals" by:

Eliminating requirements that do not permit hospital patients or their caregivers/support persons to self-administer certain medications;

Letting hospitals determine the best ways to oversee and manage outpatients by removing the unnecessary requirement for a single director of outpatient services;

Allowing one governing body to oversee multiple hospitals in a single health system;

Enabling hospitals to have a single, interdisciplinary care plan that supports coordination of care instead of requiring a separate stand-alone nursing care plan; and